Class 2 Device Recall Brilliance Big Bore Computed Tomography XRay Scanning Systems

• Date Initiated by Firm: March 26, 2012
• Date Posted: May 30, 2012
• Recall Status: Terminated on February 22, 2013
• Recall Number: Z-1692-2012
• Recall Event ID: 61762
• 510(K)Number: K012009 K033326 K033357 K060937
• Product Classification: System, x-ray, tomography, computed - Product Code JAK
• Product: Brilliance Big Bore - Model #728243, and - Model #728244, CT Scanning System is subject to recall/correction; ; Product Usage:; The Brilliance 6, 16, 40 64, Brilliance Big Bore, iCT, iCT SP and Ingenuity CT are Computed Tomography X-Ray Systems that are intended to produce cross-sectional images of the body by computer reconstruction of X-Ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment , patient, and equipment supports, components and accessories.
• Code Information: Serial numbers: 7511, 7543, 7508, 7536, 7510, 7532, 7533, 7523, 7530, 7514,7502, 7551
• Recalling Firm/ Manufacturer: Philips Medical Systems (Cleveland) Inc; 595 Miner Road; Cleveland OH 44143-2131
• For Additional Information Contact: Jose4ph Vinhais; 440-483-7000
• Manufacturer Reason for Recall: Component defect. Following their receipt of a customer complaint, Philips Medical determined that the metal blocks which support the scissor slide rails underneath the scanning table (couch) of several of the firm's CT scanning systems were not manufactured to specification and may crack.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Philips issued an 'URGENT Medical Device Correction' letter dated March 27, 2012 to all affected customers. The letter identified the affected products, problem, hazard involved, how to identify affected products, and actions to be taken by customer/user. The letter informed customers that Philips intends to dispatching service personnel to each customer site in order to correct this issue. In the meantime, the letter recommend customer to contact their Philips representative if they hear unusual noises when moving the couch vertically, or if there is unintended vertical motion of the couch. For questions contact your local Philips representative or local Philips Healthcare office. For North America and Canada contact the Customer Care Solutions Center 1-800-722-9377, option 5: Enter Site ID or follow the prompts.
• Quantity in Commerce: 12 system units were distributed in the U.S.
• Distribution: Worldwide Distribution - U.S. (Nationwide) including the states of: CA, FL,, HI, IA, IN, KY, LA, MA,, MI, MO, MS. NM, NV, OH, PA, PA, SC, TN, TX, WA, and Puerto Rico
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JAK and Original Applicant = MARCONI MEDICAL SYSTEMS, INC.; 510(K)s with Product Code = JAK and Original Applicant = PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.; 510(K)s with Product Code = JAK and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.